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Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events: The ODYSSEY OUTCOMES Trial.

Publication ,  Journal Article
Szarek, M; White, HD; Schwartz, GG; Alings, M; Bhatt, DL; Bittner, VA; Chiang, C-E; Diaz, R; Edelberg, JM; Goodman, SG; Hanotin, C; Jukema, JW ...
Published in: J Am Coll Cardiol
February 5, 2019

BACKGROUND: The ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial compared alirocumab with placebo, added to high-intensity or maximum-tolerated statin treatment, after acute coronary syndrome (ACS) in 18,924 patients. Alirocumab reduced the first occurrence of the primary composite endpoint and was associated with fewer all-cause deaths. OBJECTIVES: This pre-specified analysis determined the extent to which alirocumab reduced total (first and subsequent) nonfatal cardiovascular events and all-cause deaths in ODYSSEY OUTCOMES. METHODS: Hazard functions for total nonfatal cardiovascular events (myocardial infarction, stroke, ischemia-driven coronary revascularization, and hospitalization for unstable angina or heart failure) and death were jointly estimated, linked by a shared frailty accounting for patient risk heterogeneity and correlated within-patient nonfatal events. An association parameter also quantified the strength of the linkage between risk of nonfatal events and death. The model provides accurate relative estimates of nonfatal event risk if nonfatal events are associated with increased risk for death. RESULTS: With 3,064 first and 5,425 total events, 190 fewer first and 385 fewer total nonfatal cardiovascular events or deaths were observed with alirocumab compared with placebo. Alirocumab reduced total nonfatal cardiovascular events (hazard ratio: 0.87; 95% confidence interval: 0.82 to 0.93) and death (hazard ratio: 0.83; 95% confidence interval: 0.71 to 0.97) in the presence of a strong association between nonfatal and fatal event risk. CONCLUSIONS: In patients with ACS, the total number of nonfatal cardiovascular events and deaths prevented with alirocumab was twice the number of first events prevented. Consequently, total event reduction is a more comprehensive metric to capture the totality of alirocumab clinical efficacy after ACS.

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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

February 5, 2019

Volume

73

Issue

4

Start / End Page

387 / 396

Location

United States

Related Subject Headings

  • Middle Aged
  • Male
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Humans
  • Follow-Up Studies
  • Female
  • Drug Therapy, Combination
  • Cardiovascular System & Hematology
  • Antibodies, Monoclonal, Humanized
  • Antibodies, Monoclonal
 

Citation

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Szarek, M., White, H. D., Schwartz, G. G., Alings, M., Bhatt, D. L., Bittner, V. A., … ODYSSEY OUTCOMES Committees and Investigators, . (2019). Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events: The ODYSSEY OUTCOMES Trial. J Am Coll Cardiol, 73(4), 387–396. https://doi.org/10.1016/j.jacc.2018.10.039
Szarek, Michael, Harvey D. White, Gregory G. Schwartz, Marco Alings, Deepak L. Bhatt, Vera A. Bittner, Chern-En Chiang, et al. “Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events: The ODYSSEY OUTCOMES Trial.J Am Coll Cardiol 73, no. 4 (February 5, 2019): 387–96. https://doi.org/10.1016/j.jacc.2018.10.039.
Szarek M, White HD, Schwartz GG, Alings M, Bhatt DL, Bittner VA, et al. Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events: The ODYSSEY OUTCOMES Trial. J Am Coll Cardiol. 2019 Feb 5;73(4):387–96.
Szarek, Michael, et al. “Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events: The ODYSSEY OUTCOMES Trial.J Am Coll Cardiol, vol. 73, no. 4, Feb. 2019, pp. 387–96. Pubmed, doi:10.1016/j.jacc.2018.10.039.
Szarek M, White HD, Schwartz GG, Alings M, Bhatt DL, Bittner VA, Chiang C-E, Diaz R, Edelberg JM, Goodman SG, Hanotin C, Harrington RA, Jukema JW, Kimura T, Kiss RG, Lecorps G, Mahaffey KW, Moryusef A, Pordy R, Roe MT, Tricoci P, Xavier D, Zeiher AM, Steg PG, ODYSSEY OUTCOMES Committees and Investigators. Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events: The ODYSSEY OUTCOMES Trial. J Am Coll Cardiol. 2019 Feb 5;73(4):387–396.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

February 5, 2019

Volume

73

Issue

4

Start / End Page

387 / 396

Location

United States

Related Subject Headings

  • Middle Aged
  • Male
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Humans
  • Follow-Up Studies
  • Female
  • Drug Therapy, Combination
  • Cardiovascular System & Hematology
  • Antibodies, Monoclonal, Humanized
  • Antibodies, Monoclonal